Routine vs On-demand ECMO for Lung Transplantation

Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Study ID
NCT06615492
Status
Recruiting
Apply to this trial

Conditions

  • COPD (Chronic Obstructive Pulmonary Disease)
  • Interstitial Lung Disease (ILD)
  • Pulmonary Fibrosis
  • Respiratory Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Routine ECMO — DEVICE
    Routine intraoperative venoarterial ECMO during lung transplant
  • On-demand ECMO — DEVICE
    Selective, indication-based intraoperative cardiopulmonary support. In this group, the transplant will be planned without cardiopulmonary support. intraoperative venoarterial ECMO will be used selectively based on hemodynamic and/or gas exchange abnormalities : 1. Inability to maintain adequate hemodynamics and stable perfusion despite volume resuscitation and vasopressor administration and in the absence of readily correctable cause 2. Inability to tolerate pulmonary artery clamping 3. Inadequate gas exchange despite attempts at the optimization of ventilator parameters and treatments related to respiratory mechanics and ventilation/perfusion matching 4. Inadequate exposure to the surgical field 5. The transplant team is concerned about the ability to maintain organ perfusion or ventilate with a lung protective strategy, even if the aforementioned criteria are unmet. 6. Concerns about donor lung quality and a desire to protect the implanted lung from single lung perfusion

Study Details

Lung transplantation is a complex procedure performed in patients with terminal lung disease. The transplant procedure stresses the patient's heart and lungs, which are already taxed by the underlying disease process. The heart-lung machine is occasionally used to support the patient and ensure adequate oxygen supply to other organs during the operation. It can be used routinely in all patients or selectively in patients who exhibit reduced oxygen supply to the remaining organs. This process, known as cardiopulmonary bypass (CPB), pumps blood out of the body to a heart-lung machine that removes carbon dioxide and returns oxygen-filled blood to the body. Although using the CPB increases the risk of bleeding, infection, and coagulation complications, it should still be considered in high-risk patients to compensate for more severe complications such as kidney failure and stroke caused by a lack of cardiopulmonary support. Extracorporeal membrane oxygenation (ECMO) is a recently developed CPB variation associated with fewer bleeding complications. It has recently replaced the traditional heart-lung machine as the preferred method of cardiopulmonary support during lung transplantation. Since ECMO is associated with fewer complications than standard CPB, many centers have increased their use of ECMO during lung transplantation. Some have even employed it routinely. However, there remains significant debate on how often it should be used. Therefore, the study's main objective is to compare the two approaches in lung transplantation, i.e., routine use versus selective use, and to determine if one approach is preferable to the other.

Key Dates

Start date
Nov 5, 2024
Status verified
Dec 2025
Primary completion
Nov 5, 2028
Completion
Jan 15, 2029

Study Design

Enrollment
218 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Routine ECMO
    Routine ECMO during lung tansplant
  • Active Comparator: On-demand ECMO
    Selective, indication-based intraoperative cardiopulmonary support.

Primary Outcome Measure

ICU-free days [ Time Frame: From the end of surgery up to 28 days after surgery ]

Central Contacts

Related Studies